BEUDAMED
    FDA Enforcement Class II Ongoing

    Mammotrak Diagnostic Coil 1.5T

    Recall: Z-0541-2025 · Reported December 4, 2024

    Enforcement

    Recall Number
    Z-0541-2025
    Event ID
    95645
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2024
    Initiation Date
    November 4, 2024
    Classification Date
    November 25, 2024
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289, United States

    Description

    Mammotrak Diagnostic Coil 1.5T

    Reason

    Potential safety issue where a patient may be harmed while preparing for or during a scan.

    Code Info

    REF: 453530228872; UDI-DI: 00884838066762; Serial No. 79, 124, 71, 179, 124, 182, 45, 43, 178, 171, 181, 53, 40, 52, 69, 187, 95.

    Distribution

    US Nationwide distribution.

    Quantity

    5,231 units